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NCT ID: NCT04409444 Recruiting - Lung Cancer Clinical Trials

Manchester Lung Health Study

qUEST
Start date: August 20, 2019
Phase:
Study type: Observational

The Manchester Lung Health Study (qUEST) will assess the uptake of a community-based lung cancer screening service and its impact across a deprived area of North and East Manchester, which has high rates of lung cancer. One measure will be to compare the number and stage of lung cancers detected through screening to those detected outside of screening. In addition we will investigate the potential of a blood and nose test to detect lung cancer or to help decide who would benefit from screening. We will also see if these samples can help with the interpretation of CT scans. One of the problems with lung cancer CT screening is that you detect lung nodules in which we are not sure if they are benign or cancerous. Therefore we are also looking to see if a biomarker can help us work out which are cancerous and which are benign.

NCT ID: NCT04409080 Recruiting - Clinical trials for Severe Aplastic Anemia (SAA)

REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy

Start date: January 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is researching an experimental drug called REGN7257 (called "study drug"). The study is focused on patients who have severe aplastic anemia (SAA), a disease of the bone marrow resulting in an impairment of the production of blood cells. The main purpose of this two-part study (Part A and Part B) is to test how safe and tolerable REGN7257 is in patients with SAA in which other Immunosuppressive therapies (ISTs) have not worked well. The study is looking at several other research questions to better understand the following properties of REGN7257: - Side effects that may be experienced by participants taking REGN7257 - How REGN7257 works in the body - How much REGN7257 is present in blood after dosing - If REGN7257 works to raise levels of certain blood counts after treatment - How quickly REGN7257 works to raise levels of certain blood counts - In patients for whom REGN7257 works to raise levels of certain blood counts after treatment, how many continue to show such a response throughout the study - If REGN7257 works to lower the number of platelet and red blood cell transfusions needed - How REGN7257 changes immune cell counts and composition - How the body reacts to REGN7257 and if it produces proteins that bind to REGN7257 (this would be called the formation of anti-drug antibodies [ADA])

NCT ID: NCT04408755 Recruiting - Clinical trials for Agitation in Patients With Dementia of the Alzheimer's Type

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Start date: July 8, 2020
Phase: Phase 3
Study type: Interventional

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

NCT ID: NCT04408638 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Start date: February 23, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

NCT ID: NCT04408625 Recruiting - Clinical trials for Frontotemporal Dementia

Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)

PROCLAIM
Start date: November 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two escalating dose (low dose and medium dose) cohorts are planned, as well as one bridging cohort which will allocate patients to receive either low or medium dose. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884963 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes.

NCT ID: NCT04408365 Recruiting - COVID Clinical Trials

Endothelial Function, Inflammation and Organ Dysfunction in COVID-19

Start date: August 5, 2020
Phase:
Study type: Observational

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients which require intensive care unit admission. In critically ill patients infected with COVID-19, approximately 15% had severe shock requiring medications to increase blood pressure. It appears that blood vessel tone is altered and microcirculation is not well regulated in patients with COVID-19. The underlying pathophysiology and contributing factors are unknown. The association with subsequent organ dysfunction and outcome is also unclear. Therefore, the investigators aim to investigate serial changes of relevant biomarkers in this population to improve the understanding of this disease, to investigate the association with clinically important outcomes and to find out how best to treat patients. The data will serve to develop strategies for individualised management of this high-risk group.

NCT ID: NCT04408326 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Efficacy and Safety of Angiotensin II Use in Coronavirus Disease(COVID)-19 Patients With Acute Respiratory Distress Syndrome

ACES
Start date: June 1, 2020
Phase:
Study type: Observational

This study aims to find out whether the use of angiotensin II, which is a drug to raise blood pressure has been approved by European Medical Agency in August 2019, as an add-on medication to increase blood pressure in patients with COVID-19, acute severe lung injury, inflammation and severe shock, compared with standard medication. In addition, the investigators will collect the data of Anakinra, another drug which is frequently used in this condition to reduce inflammation. The investigators will collect clinical data and outcomes from critical care patients. The investigators will analyse for whom these drugs are most beneficial and explore whether there are any patients who don't benefit or have side effects.

NCT ID: NCT04408248 Recruiting - Acute Kidney Injury Clinical Trials

AKI Biomarkers in Coronavirus(COVID)-19

Start date: August 20, 2020
Phase:
Study type: Observational

This research aims to investigate the role of daily measurement of urinary cell cycle arrest markers and other serum and urinary biomarkers to predict the development of acute kidney injury in critically ill patients with COVID-19 and acute respiratory disease.

NCT ID: NCT04407676 Recruiting - Solid Neoplasms Clinical Trials

Improving Informed Consent for Early Phase Anti-Cancer Trials

CONSENT
Start date: June 26, 2020
Phase: N/A
Study type: Interventional

The purpose of the trial will be to test whether providing both a short summary PIS and a link to a set of online video modules will improve patient understanding (those considering early phase clinical trials) as measured on the Quality of Informed Consent questionnaire (Part A), as compared to a control group who are provided only the normal PIS, and also to assess user acceptability and feasibility of these interventions.

NCT ID: NCT04407650 Recruiting - Clinical trials for Gestational Diabetes

Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus

GUARD
Start date: July 1, 2021
Phase: Phase 4
Study type: Interventional

GUARD is a Clinical Trial that wants to explore the impact of UDCA compared to metformin in the treatment of GDM. The trial wants to recruit 158 women who are overweight or obese who have been diagnosed with GDM, and require pharmacological treatment. Glucose control is our primary measure. Each year in the UK approximately 35,000 women develop diabetes during pregnancy, a condition called gestational diabetes mellitus (GDM), which increases the risk of adverse outcomes for both mother and child. Metformin, although unlicensed for used in pregnancy, is the most commonly used first line pharmacological treatment. However, there is increasing concern about its widespread use during pregnancy, because of its limited efficacy and because of potential safety concerns. Other common treatments have not been shown to be superior. Therefore, there is an unmet need for additional therapies. Ursodeoxycholic acid (UDCA) is commonly used in pregnancy for the treatment of intrahepatic cholestasis of pregnancy. It is currently not an established/licensed treatment for GDM. However data from observational studies of women with cholestasis in pregnancy has flagged this to be a potential effective treatment to control blood glucose levels in GDM. The investigators will ask women to attend three study visits, which will coincide with the time of their antenatal appointments. The trial aims to collect a range of clinical and research blood samples, to measure quality of life and treatment satisfaction through two questionnaires, and will will ask women to wear a continuous glucose monitor for three 10 day periods. There will be a number of optional assessments that participants will be offered. The primary outcome will be the fasting blood glucose concentration at 36 weeks of gestation. The investigators intend to carry out this study at 3 sites in the United Kingdom (Guy's and St Thomas, Imperial College and Nottingham), and it has been funded by a J.P Moulton Foundation grant.